Pradaxa (dabigatran etexilate mesylate)

The prescription drug Pradaxa (dabigatran etexilate mesylate) is a medication which has been prescribed to hundreds of thousands of patients to thin their blood thereby reducing the risk of stroke and blood clots when they have certain underlying heart disease such as atrial fibrillation or heart valve problems, but not artificial heart valves. On December 19, 2012, the United States Food and Drug Administration issued the following Safety Communication about Pradaxa: “The U.S. Food and Drug Administration (FDA) is informing health care professionals and the public that the blood thinner (anticoagulant) Pradaxa (dabigatran etexilate mesylate) should not be used to prevent stroke or blood clots (major thromboembolic events) in patients with mechanical heart valves, also known as mechanical prosthetic heart valves. A clinical trial in Europe (the RE-ALIGN trial) was recently stopped because Pradaxa users were more likely to experience strokes, heart attacks, and blood clots forming on the mechanical heart valves than were users of the anticoagulant warfarin. There was also more bleeding after valve surgery in the Pradaxa users than in the warfarin users.”

Warfarin (Brand names include Coumadin, Jantoven, and Uniwarfin) has been on the United States market since about 1954. This well-known anticoagulant continues to be commonly prescribed to patients who are at risk of blood clots which can lead to serious consequences such as stroke and death. While warfarin has been time-tested and proves itself to be quite effective, and relatively safe (“safe” based on a risks and benefits analysis which considers the serious consequences of not anticoagulating patients at high risk of clotting). To maintain safety while taking warfarin, a patient must allow blood levels to be tested about every three months (to make sure there is not too much or too little in a patient’s system) and avoid foods which contain Vitamin K (such as many leafy green vegetables) which can render warfarin ineffective. Failure to take warfarin exactly as prescribed and to monitor warfarin levels can lead to uncontrolled bleeding which if not treated emergently can cause a patient to bleed to death. Fortunately, there are several antidotes to warfarin toxicity – all of which are commonly available to healthcare professionals. Antidotes include injectable Vitamin K, plasma (fresh frozen or cryosupermatant plasma), prothrombin complex concentrates, and recombinant factor VIIa.

One of the big “selling” points for Pradaxa as opposed to warfarin is that the patient taking Pradaxa does not have to submit himself or herself to regular blood draws and dietary restrictions. What promoters of Pradaxa conveniently do not tell physicians and patients is that there is no commonly available antidote for a Pradaxa overdose. Thus, should a patient’s Pradaxa levels reach a toxic level, he or she has a good chance of bleeding to death while physicians watch helplessly. Pradaxa levels are effected by advanced age, renal (kidney) function, extremes in body weight, and drug-drug interactions (aspirin, ibuprofen, nonsteroidal antiinflammatory drugs, and many other commonly used drugs). According to the National Center for Biotechnology Information, “In early 2013, there is still no routine coagulation test suitable for monitoring these patients; specific tests are only available in specialized laboratories. In early 2013 there is no antidote for dabigatran, rivaroxaban or apixaban, nor any specific treatment with proven efficacy for severe bleeding linked to these drugs. Recommendations on the management of bleeding in this setting are based mainly on pharmacological parameters and on scarce experimen-Haemodialysis reduces the plasma concentration of dabigatran, while rivaroxaban and apixaban cannot be eliminated by dialysis.”

In the last few years, several thousand patients, who have suffered serious injuries including death, have sued Boehringer Ingelheim Pharmaceuticals, Inc., the manufacturer of Pradaxa for failing to warn patients and their physicians about the serious adverse events that may result from taking Pradaxa. Many of these suits also allege that Boehringer promoted Pradaxa as being safer than warfarin.

If your physician has prescribed Pradaxa for you, you should immediately discuss whether there are safer alternative drugs for you. After weighing the risks and benefits, you and your physician can determine what drug is best for you. If you have taken Pradaxa, and have suffered uncontrollable bleeding, you should know that attorney and physician Paul J. Molinaro is available to answer your legal questions and help you determine whether you are entitled to compensation from the manufacturer of this drug. You can reach Paul J. Molinaro, M.D. J.D. toll free at (888)MDJDLAW. The initial consultation is also free, and if Paul determines that you have a case, and you decide to hire Paul, he will represent you on a contingent basis.

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